Lanreotide In Polycystic Kidney Disease Study
NCT02127437 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159
Last updated 2026-04-08
Summary
LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.
An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.
Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD
Interventions
- DRUG
-
Lanreotide
120 mg, subcutaneously, once every 4 weeks
- DRUG
-
saline
0,5 ml, subcutaneously, once every 4 weeks
Sponsors & Collaborators
-
IPSEN pharmaceutical company, Boulogne-Billancourt, France
collaborator UNKNOWN -
URC-CIC Paris Descartes Necker Cochin
collaborator OTHER -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Dominique JOLY, MD, PhD · Necker hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-19
- Primary Completion
- 2019-07-31
- Completion
- 2019-07-31
Countries
- France
Study Locations
More Related Trials
-
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
NCT03832114 ·Status: COMPLETED ·Phase: PHASE2
-
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
NCT01022424 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
NCT02232763 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
NCT02837237 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
NCT03545087 ·Status: WITHDRAWN ·Phase: PHASE1
-
Tolvaptan Extension Study in Participants With ADPKD
NCT01214421 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
NCT02160145 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)
NCT02964273 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease
NCT04064346 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
NCT04786574 ·Status: WITHDRAWN ·Phase: PHASE3
-
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
NCT02251275 ·Status: COMPLETED ·Phase: PHASE3
-
Lorlatinib Renal Impairment Study
NCT03542305 ·Status: COMPLETED ·Phase: PHASE1
-
Pilot Study of Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of RP103 Compared to Cystagon® in Patients With Cystinosis
NCT00872729 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT00428948 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
NCT04152837 ·Status: TERMINATED ·Phase: PHASE3
-
Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
NCT01197378 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
NCT06291116 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT00346918 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD)
NCT04782258 ·Status: RECRUITING ·Phase: PHASE3
-
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
NCT03487913 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
NCT01210560 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function
NCT05611957 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function of Similar Age, Gender, and Weight
NCT05515432 ·Status: COMPLETED ·Phase: PHASE1
-
Losartan to Reverse Sickle Nephropathy
NCT01479439 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment
NCT07165015 ·Status: COMPLETED ·Phase: PHASE1